(87 days)
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No
The summary describes a simple syringe and a laser alignment system, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a syringe used for injecting or retracting fluids, which is a diagnostic or procedural tool, not a therapeutic device meant to treat or cure a disease. The laser alignment system improves accuracy, but the core function is fluid management.
No
Explanation: The device is described as a syringe for injecting or retracting fluids, which is a therapeutic or interventional function, not a diagnostic one. While it mentions accuracy with a laser alignment system, this is related to the precision of fluid delivery, not the identification or assessment of a medical condition.
No
The device description explicitly states it is a "Single use disposable syringe," which is a physical hardware component. It also mentions being used with a "DRTS™ Laser Alignment System" and a "Light Saber™ Syringe," further indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or retract fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for examining samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health status. This device does not fit that description.
The additional information about the laser alignment system and accuracy further reinforces that this is a device used for procedures performed directly on the patient, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
"Single use disposable syringe to inject fluids into, or retract fluids from the body" "When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle."
Product codes
FMF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a staff entwined by snakes, often used as a symbol of medicine. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1998
Mr. Thomas L. Parker ·Director, Regulatory Affairs MINRAD™ Incorporated 6576 East Quaker Street Orchard Park, New York 14127-2593
Re : K981140 MINRAD DRTS Light Saber™ Syringe Trade Name: Requlatory Class: II Product Code: FMF Dated: March 23, 1998 Received: March 30, 1998
Dear Mr. Parker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Pleáse note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Parker
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html"
Sincerely yours,
Timothy A. Ulatowski
A. Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5
INDICATIONS FOR USE
MINRAD LIGHT SABER™ SYRINGE
"Single use disposable syringe to inject fluids into, or retract fluids from the body"
"When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle."
Patricia Cucciate
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devi 510(k) Number K98 1
Prescription use ✓
(Per 21CFR 801.109)